摘要
目的:建立乙酰半胱氨酸细菌内毒素检查方法。方法:按照《中国药典》2020年版四部通则1143细菌内毒素凝胶检查法进行方法学验证和细菌内毒素检查。结果:最大不干扰浓度为3.125 mg·mL^(-1),使用0.06 EU·mL^(-1)的鲎试剂,对鲎试剂与内毒素反应无干扰影响,三批乙酰半胱氨酸细菌内毒素检查均符合规定。结论:本法可用于乙酰半胱氨酸的质量控制。
Objective:Toestablisha method for determining bacterial endotoxin of acetylcysteine.Methods:According to the bacterial endotoxin test gel method in the general chapter 1143,Chinese Pharmacopoeia 2020 VolⅣ,validation test was performedto verify the bacterial endotoxin test of acetylcysteine.Results:There was no reaction interference between tachypleus amebocyte lysate and bacterial endotoxins when the maximal non-interference concentration was 3.125 mg·mL^(-1) and 0.06 EU·mL^(-1) tachypleus amebocyte lysate were used.Three batches of bacterial endotoxin test of acetylcysteine all met the requirements.Conclusion:The bacterial endotoxin test established can be used for the quality control of acetylcysteine.
作者
方选
于德志
武刚毅
FANG Xuan;YU Dezhi;WU Gangyi(Qingdao Institute for Food and Drug Control,Qingdao 266071,China;Qingdao Municipal Hospital,Qingdao 266071,China)
出处
《中国药品标准》
CAS
2022年第2期220-223,共4页
Drug Standards of China
关键词
乙酰半胱氨酸
细菌内毒素
鲎试剂
干扰试验
acetylcysteine
bacterial endotoxin
tachypleus amebocyte lysate
interference test
